Conor O’Brien, analyst and report author, Prohibition Partners
September 9, 2021
Research into the endocannabinoid system is currently one of the most promising avenues for new therapeutics in medicine. However, with changing regulations and advances in cannabinoid research, the ground is constantly shifting under the feet of operators in the cannabis industry. The ability of scientists and companies to serve patients depends not least on their ability to navigate a changing landscape of governance and new cannabis therapeutics. The Pharmaceutical Cannabis Report: 2nd Edition was compiled to help interested parties understand the medical cannabinoid market and where it could head.
The vast majority of medicinal cannabis used to date has been in the form of products such as flowers and oils that have not been approved for clinical trials through the traditional process. Instead, medical cannabis products have largely reached patients through dedicated access routes that allow medically supervised treatment for a particular cannabinoid product in the absence of clinical trial results. This system has made it possible to deliver regulated, safe products to patients who would otherwise have obtained cannabis on the black market. However, the current regulatory system, e.g. in Europe and North America, raises questions about the precision of the dosage and the certainty of the use of certain cannabis strains under certain conditions.
In many western states, there are two concurrent trends in cannabis regulation that will affect the balance between fully legal and medicinal cannabis products. The first is that many regions are moving towards the use of more precise medicinal cannabis products such as extracts and medicines. For example, the graph below shows how the popularity of oils in Canada may be at the expense of cannabis flower use, and a similar trend can be seen in some European countries. A notable exception is that flowers retain their dominant position in most of the medical markets in the United States.
The second trend is the progress in legalizing adult cannabis use, which is already attracting some medical cannabis patients and is likely to reduce the patient population to those who are predominantly medical users.
In contrast to the use of unapproved medical cannabis products, the use of pharmaceutical cannabinoid products is increasing worldwide. These are products like Sativex® and Nabilone® that have gone through the standard clinical trial process to be fully approved by agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA). in Europe. Pharmaceutical cannabis products are preferred by many regulators, doctors, and insurers as they are credited with a stronger evidence base and higher production standards, both in terms of purity and the precision of cannabinoid content.
Epidiolex ® is currently the “flagship” for the success of pharmaceutical cannabinoid products and achieved sales of over 430 million euros in 2020. The Pharmaceutical Cannabis Report: 2nd Edition traces a detailed story of how GW Pharmaceuticals managed to develop the most successful pharmaceutical cannabis drug to date and examines how it could be replicated in the future.
What future cannabinoid therapies will look like is far from certain. The field is currently brimming with innovation, so this Pharmaceutical Cannabis Report offers an in-depth analysis of the advances made in the following areas:
- The use of novel and minor cannabinoids such as cannabigerol (CBG) and cannabinol (CBN);
- The chemical and biosynthesis of cannabinoids outside the cannabis plant and their commercial viability;
- The current and future patent and intellectual property issues surrounding medical cannabis;
- New devices and methods for delivering medicinal cannabinoids.
In the report, Prohibition Partners speak to two leaders in cannabis treatment innovation, Dr. Peter Grinspoon of Harvard Medical School and Sean Jarvis of Pureform Global (a life science company focused on the discovery and production of pure cannabinoids) with interview excerpts provided here.
Interview excerpt: Sean Jarvis, Chief Strategy Officer and founder of Pureform Global
Q. Why did your company choose the chemical synthesis route instead of biosynthesis or plant cultivation for cannabinoid production?
A. All methods have advantages and disadvantages. With plant production, you have several drawbacks, such as the real difficulty of making sure the product is “pure” in the sense of being completely free of THC, other cannabinoids, terpenes, pesticides, and other undesirable and unknown contaminants. In addition, the environmental impact of plant cultivation and other synthetic methods is significant and unsustainable. It could work now. But when consumers and regulators start focusing on water use and carbon footprint in other methods, we think this will be a problem for them.
Q. Do you see synthesis replacing plant cultivation in the future?
A. While we see synthesis taking an ever larger market share, we don’t see it replacing plant cultivation. This is mainly due to cultural reasons. There is a deeply ingrained culture surrounding the use of the cannabis plant for both recreation and medicine. In many cases you need the precision and purity that synthesis can provide, but in other cases patients and customers simply prefer to consume plant material. Hardly anything about this will change in the near future. There is always the possibility of enriching plant material with chemically identical synthesized cannabinoids in post-harvest processes, for which we support customers today.
Interview excerpt: Dr. Peter Grinspoon, Harvard Medical School
Q. Which aspect of the smaller cannabinoids are you most excited about?
A. I’m very excited about the possibility that we can use smaller cannabinoids to fight some of the most common diseases in the western world. First and foremost, I am thinking of the cannabinoid THC-V in the cannabis plant, which has potential therapeutic efficacy against obesity and diabetes. THC-V can promote weight loss in rodent models even when the doses given are quite low. The prevalence of obesity among adults in the United States is over 40% and costs the country up to $ 200 billion in health care and lost productivity each year. If we could find a way to safely use the endocannabinoid system to treat this, the implications would be enormous.
Q. Should companies emulate groups like GW in developing cannabinoid drugs?
A. This is a complicated subject. On the one hand, groups like GW have done important research when many other people were unable to do so at this point in history. Some of the benefits of this have been the speeding up of research and education on the cannabinoid system, not to mention the production of some of the first successful cannabinoid drugs on the market (…) This is a bit of a double-edged as we patients are desire access to unpatented herbal cannabinoids as a rich health resource, but we also rely on large institutions to conduct some of the costly research examining the clinical trials of the endocannabinoid system.
For more information, the executive summary of The Pharmaceutical Cannabis Report: 2nd Edition can be downloaded here. For press inquiries, please contact Michael Hoban (email@example.com).
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Prohibition Partners unlocks the potential of cannabis through data, intelligence and strategy. We provide strategic solutions and advisory services to an international client base of investors, operators, blue chip companies, FMCG brands and government agencies.